(217 days)
The Mark 5 Nuvo (M5C5) Oxygen Concentrator is intended solely for medical use in oxygen therapy programs under the supervision of a physician. This device is available by prescription only and is not intended to support or sustain life.
The Mark 5 Nuvo (M5C5) oxygen concentrator is an AC powered device that provides a high level of inspired oxygen by separating oxygen from ambient air utilizing pressure swing adsorbers (PSA). Air is drawn into the device with a piston-type compressor and exposed to molecular sieve adsorbent that selectively retains nitrogen and other components until they are released when the pressure is vented to the atmosphere. This cycle is controlled by a motorized rotary 4-way valve and protected from over pressurization by the compressor's pressure relief valve. The device provides a nominal oxygen enriched gas concentration of 90 ±3% at a flow rate of 5 l/min ±10%. It is not a life-supporting, life-sustaining or sterile device.
The Mark 5 Nuvo (M5C5) oxygen concentrator is a durable, reusable, semi-portable unit weighing approximately 50 pounds [23 kg]. The device is available in both 115V and 230V models that have been designed and validated according to applicable requirements of EN 60601-1-2:2001, IEC 60601-1-2:2001, UL 60601-1:2003, and CAN/CSA-C22.2 No 601.1-M90 with A1 & A2:1999 as appropriate to the area of usage. The Mark 5 Nuvo (M5C5) oxygen concentrator is intended to be used with one of the many legally marketed humidifiers, connecting tubing and nasal cannula as prescribed. One of these devices may optionally be included with the device.
Here's a breakdown of the acceptance criteria and the study information for the Nidek Medical Products, Inc. Mark 5 Nuvo (M5C5) Oxygen Concentrator, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary for the Nidek Mark 5 Nuvo (M5C5) Oxygen Concentrator primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting specific acceptance criteria and their direct fulfillment in a table. However, we can infer some key performance metrics and the reported device performance from the "Device Description" section and the "Nonclinical Performance" section.
| Acceptance Criterion (Inferred from Device Description/Performance) | Reported Device Performance |
|---|---|
| Oxygen Enriched Gas Concentration | 90 ±3% |
| Flow Rate | 5 l/min ±10% |
| Operating Power | AC powered (115V and 230V models) |
| Weight | Approximately 50 pounds [23 kg] |
| Safety Standards Compliance | EN 60601-1-2:2001, IEC 60601-1-2:2001, UL 60601-1:2003, and CAN/CSA-C22.2 No 601.1-M90 with A1 & A2:1999 (as appropriate to the area of usage) |
Note on Acceptance Criteria: It's important to understand that for a 510(k) submission, the primary "acceptance criterion" is generally substantial equivalence to a predicate device. This means the new device performs as safely and effectively as a legally marketed device. The performance specifications listed above are the design specifications that were likely established to meet the intended use and demonstrate equivalence, rather than explicitly stated "acceptance criteria" against which a study was formally tested and presented in a table in this summary.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a "test set" in the context of clinical studies with a specific sample size. The performance testing conducted was nonclinical.
- Sample Size: Not applicable for a traditional test set involving patient data. The testing was performed on the device itself. The number of units tested is not specified but would typically involve one or more production or prototype units under various conditions.
- Data Provenance: The testing was nonclinical, conducted at Intertek Testing Services NA Inc. located at Duluth, GA. This indicates laboratory-based testing, not human subject data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The testing was nonclinical and involved adherence to recognized safety and performance standards. There was no "ground truth" derived from expert consensus on patient data. The "ground truth" for nonclinical performance is compliance with engineering and safety standards.
4. Adjudication Method for the Test Set
Not applicable. There was no expert adjudication process for this nonclinical performance testing.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No. This document describes a 510(k) submission for an oxygen concentrator, which involves a nonclinical performance evaluation against recognized standards and a comparison of technological characteristics to a predicate device. MRMC studies are typically used for diagnostic or screening devices where human readers interpret medical images or data, and an AI's impact on their performance is being evaluated.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
Yes, in a conceptual sense. The "Nonclinical Performance" testing was a standalone evaluation of the device's adherence to applicable safety and electrical standards. The device itself (the oxygen concentrator) was tested independently without human-in-the-loop performance being a relevant parameter for its primary function of producing oxygen.
7. The Type of Ground Truth Used
For the nonclinical performance testing, the "ground truth" was compliance with established international and national electrical, medical device safety, and electromagnetic compatibility standards (EN 60601-1-2:2001, IEC 60601-1-2:2001, UL 60601-1:2003, and CAN/CSA-C22.2 No 601.1-M90 with A1 & A2:1999).
For the substantival equivalence comparison, the "ground truth" was the performance and design of the predicate device (Mark-5 (M5C5) Concentrator, K883591, and Model 590 Oxygen Concentrator, K895141).
8. The Sample Size for the Training Set
Not applicable. This device is a physical medical device (an oxygen concentrator) and does not involve AI or machine learning algorithms that would require a "training set" of data in the computational sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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MAR 1 8 2004
510(k) Summary
| 510(k)Summary | This summary of 510(k) safety and effectiveness information is beingsubmitted in accordance with the requirements of 21 C.F.R. § 807.92. | ||
|---|---|---|---|
| Submitter | Nidek Medical Products, Inc. | ||
| Contact Person | Jennifer McWilliams, Quality Assurance Manager3949 Valley East Industrial DriveBirmingham, AL 35217Phone (205) 856-7200 ext. 215Fax (205) 856-0563jmcwilliams@nidekmedical.com | ||
| Date Prepared | August 12, 2003 | ||
| Name | Mark 5 Nuvo (M5C5) | ||
| ClassificationNames | Oxygen Concentrator | ||
| DeviceClassification | Classification: Generator, Oxygen PortableClassification Panels: AnesthesiologyRegulation Number: 21CFR 868.5440 | ||
| PredicateDevice(s) | |||
| Mark-5 (M5C5) ConcentratorModel 590 Oxygen Concentrator | K883591K895141 | November 2, 1988October 31, 1989 | |
| PerformanceStandards | Performance standards have not been established by the FDA undersection 514 of the Federal, Food, Drug and Cosmetic Act | ||
| DeviceDescription | The Mark 5 Nuvo (M5C5) oxygen concentrator is an AC powereddevice that provides a high level of inspired oxygen by separatingoxygen from ambient air utilizing pressure swing adsorbers (PSA).Air is drawn into the device with a piston-type compressor andexposed to molecular sieve adsorbent that selectively retains nitrogenand other components until they are released when the pressure isvented to the atmosphere. This cycle is controlled by a motorizedrotary 4-way valve and protected from over pressurization by thecompressor's pressure relief valve. The device provides a nominaloxygen enriched gas concentration of 90 ±3% at a flow rate of 5l/min ±10%. It is not a life-supporting, life-sustaining or steriledevice | ||
| Device Description Continued | The Mark 5 Nuvo (M5C5) oxygen concentrator is a durable, reusable, semi-portable unit weighing approximately 50 pounds [23 kg]. The device is available in both 115V and 230V models that have been designed and validated according to applicable requirements of EN 60601-1-2:2001, IEC 60601-1-2:2001, UL 60601-1:2003, and CAN/CSA-C22.2 No 601.1-M90 with A1 & A2:1999 as appropriate to the area of usage. The Mark 5 Nuvo (M5C5) oxygen concentrator is intended to be used with one of the many legally marketed humidifiers, connecting tubing and nasal cannula as prescribed. One of these devices may optionally be included with the device. | ||
| Indications for Use | The Mark 5 Nuvo (M5C5) Oxygen Concentrator is intended solely for medical use in oxygen therapy programs under the supervision of a physician. This device is available by prescription only and is not intended to support or sustain life. | ||
| Technological Characteristics | The Mark 5 Nuvo (M5C5) contains features and functions that are similar to the Mark-5 (M5C5) concentrator. The following table briefly describes the proposed changes that do not affect the intended use or alter the fundamental scientific technology of the device. | ||
| Component | Predicate Device | Proposed Device | |
| Compressor Cooling | Squirrel Cage Blower | Tubeaxial Fan | |
| Molsiv Adsorbent | MO2 | OxySiv | |
| Flow Control | Selectable Fixed-Orifice Valve | Flow Meter (Thorpe Tube) | |
| Outlet Pressure | 9 PSI | 7 PSI | |
| Circuit Breaker | none | 10 Amp | |
| Cabinet Dimensions | Rectangular Design | Contoured Design | |
| Compressor Support | Natural Rubber Isolators | Steel Springs | |
| Labeling | Words | Symbols | |
| Pressure Measurement | Pressure Switches | Pressure Sensor | |
| Nonclinical Performance | The device was tested to applicable requirements EN 60601-1-2:2001, IEC 60601-1-2:2001, UL 60601-1:2003, and CAN/CSA-C22.2 No 601.1-M90 with A1 & A2:1999 as appropriate to the area of usage. Testing was conducted in June 2003 at Intertek Testing Services NA Inc. located at Duluth, GA. and documented in report numbers 3040276-27-1-1and 3040276A. | ||
| Conclusion | The Mark 5 Nuvo (M5C5) is substantially equivalent to the legally marketed Mark-5 (M5C5) concentrator. |
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling a symbol. The symbol is a stylized representation of a bird-like figure, possibly an eagle, with three wing-like shapes above a wavy line, suggesting water or movement.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 8 2004
Ms. Jennifer McWilliams Quality Assurance Manager Nidek Medical Products, Incorporated 3949 Valley East Industrial Drive Birmingham, AL 35217
Re: K032509
Trade Name: Mark 5 Nuvo (M5C5) Regulation Number: 21 CFR 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: II Product Code: CAW Dated: February 18, 2004 Received: February 20, 2004
Dear Ms. McWilliams:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Security premation is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule, to regary manetee to fithe Medical Device Amendments, or to commerce prior to May 20, 1970, the enacember with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Costience Act (Act) that to not require appro the general controls provisions of the Act. The
You may, therefore, market the device, subject to the general controls pro You may, merefore, market the devrees, saloject to an all registration, listing of the general controls provisions of the Fisc labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see aboro) als. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major may be subject to such additional occurrents, Title 21, Parts 800 to 898. In addition, FDA may be found in the Code of Productions
publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that IDA's issualled of a sualies with other requirements of the Act
that FDA has made a determination that your device complies . You must that FDA has made a decemmancia in administered by other Federal agencies. You must on and lists or any Federal statures and regulations daminders but not limited to: registration and listing (21 let comply with an the Act s requirements, morealing, arenes, and manufacturing practice requirements as set
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Page 2 -- Ms. Jennifer McWilliams
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
tinger
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Item #7
Indications for Use
510(k) Number (if known): K032509
Mark 5 Nuvo (M5C5) Device Name:
The Mark 5 Nuvo (M5C5) Oxygen Concentrator is Indications for Use: intended solely for medical use in oxygen therapy programs under the supervision of a physician. This device is available by prescription only and is not intended to support or sustain life.
Prescription Use __ × (Part 21 CFR 801 Subpart D) AND/O ಗಿ
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE: ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sottwle
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number: K032509
Page __ of ____
ber: 5037
§ 868.5440 Portable oxygen generator.
(a)
Identification. A portable oxygen generator is a device that is intended to release oxygen for respiratory therapy by means of either a chemical reaction or physical means (e.g., a molecular sieve).(b)
Classification. Class II (performance standards).